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Completed

NCT Number: NCT04235088

Impact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral Cerebral Palsy

This study aims to investigate the effectiveness of an intensive somatosensory intervention in the upper limb of children with hemiparesis regarding structure, function, activity and participation

Hypothesis:

Intensive somatosensory activity based intervention is effective in upper limb and hand ability in children with hemiparesis, specially regarding activity and participation

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Key information

Conditions

Unilateral Cerebral Palsy

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asociación para la Investigación en la Discapacidad Motriz (AIDIMO)

Zaragoza, 50011, Spain

About this study

Feasibility and longitudinal study with blinding of the evaluator and the person analyzing the data. The study have 3 procedures:

  • - Assessment pre-intervention
  • - Intervention: three weeks
  • - Assessment post-intervention

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of unilateral cerebral palsy
  • Manual Ability Classification System (MACS): levels I, II y III.
  • Gender: male and female
  • Age: 6 to 15 years old

Exclusion criteria

  • Existence of a moderate or severe cognitive impairment, which could interfere with the comprehension of the tester cues
  • Botulinum toxic infiltration 4 months before the date of the pre-intervention assessment or during intervention or during the 3 months after the final intervention
  • To have suffered any injury such as fractures and/or contusions in the upper limb in the last 12 months
  • Orthopedic intervention in the 6 months preceding the study or during the study

Treatment and study plan

Somatosensory intensive intervention

Other

The intensive somato-sensory intervention will take place during 3 weeks, 5 days per week, for 2 hours per day (30 hours of practice). During the week-ends, some somato-sensory written activities will be explained and handed to each family (6 hours of practice) Therapy sessions will be carried out in groups and each child will have his or her own therapist in charge of his or her treatment along the whole intervention. A daily check-list, design for that purpose, will be used by the therapist in order to register the gradually increased complexity of the activities and individual progression. The principal investigator will supervise all the interventions in order to assure their uniformity, adjusting the somato-sensory training protocol to the individual needs of each subject.

Primary outcomes

  1. Change in Canadian Occupational Performance Measure (COPM).

    Time frame: baseline, immediately after intervention

    Participation measure (family aims). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.

  2. Change in Children´s hand-use Experience Questionnaire (CHEQ).

    Time frame: baseline, immediately after intervention

    Activity Measure (bimanual performance). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.

Secondary outcomes

  1. Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).

    Time frame: baseline, immediately after intervention

    Activity measure (daily activities, mobility, social/cognitive and responsibility).

  2. Change in Jebsen Taylor Hand Function Test.

    Time frame: baseline, immediately after intervention

    Activity Measure (unimanual capacity).

  3. Change in Box and Blocks Test.

    Time frame: baseline, immediately after intervention

    Activity measure (unilateral gross manual dexterity).

  4. Change in Sensory Profile™ 2 family Questionnaire (Winnie Dunn)

    Time frame: baseline, immediately after intervention

    Evaluate a child's sensory processing patterns in the context of home, school, and community-based activities.

  5. Change in Kidscreen Questionnaire.

    Time frame: baseline, immediately after intervention

    Participation measure (Quality of live).

  6. Change in Somatosensory Battery Assessment.

    Time frame: baseline, immediately after intervention

    Body structures and functions measure. Includes: registration (Semmes Weinstein monofilaments); Two points discrimination (Aesthesiometer); Single Point Location; double simultaneous, forms stereognosis (Manual Form Perception Test_ SIPT), stereognosis of familiar objects, graphesthesia (SIPT), clinical observation of texture perception, clinical observation of proprioception, pain (algometer) and functional sensitivity (Box and Blocks without vision).

  7. Change in Dynamometer (grip strength)

    Time frame: baseline, immediately after intervention

    Body structures and functions measure (grip strength).

  8. Change in Pinch Gauge (pinch strength).

    Time frame: baseline, immediately after intervention

    Body structures and functions measure (pinch strength).

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Registry information

Official study title

Impact of Somatosensory Intensive Intervention on Motor Performance of the Upper Limb and Participation in Children With Unilateral Cerebral Palsy: a Feasibility Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 21, 2020
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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